美国专利持续申请制度在药物研发及专利布局中的应用  

The application of subsequent application system of the United States patent in drug research and development and patent layout

作　　者：黄璐[1,2,3,4,5] 刘哲 葛凡[7] 孙建 张长春 钱丽娜 HUANG Lu;LIU Zhe;GE Fan;SUN Jian;ZHANG Chang-chun;QIAN Li-na(School of Pharmaceutical Sciences,Wuhan University,Wuhan 430072,China;School of Chemical Engineering and Pharmacy,Wuhan Institute of Technology,Wuhan 430205,China;School of Law,Humanities and Society,Wuhan University of Technology,Wuhan 430070,China;Law and Business School of Wuhan Institute of Technology(School of Intellectual Property),Wuhan 430205,China;Guangzhou BioBlue Technology Co.,Ltd.,Guangzhou 510200,China;Humanwell Healthcare(Group)Co.,Ltd.,Wuhan 430075,China;FIWIS Intellectual Property Law Firm,Beijing 100032,China;Kanazawa Institute of Technology,Tokyo 105-0002,Japan;Wuhan Optics Valley Bioindustry Base Construction and Investment Co.,Ltd.,Wuhan 430075,China)

机构地区：[1]武汉大学药学院,武汉430072 [2]武汉工程大学化工与制药学院,武汉430205 [3]武汉理工大学法学与人文社会学院,武汉430070 [4]武汉工程大学法商学院(知识产权学院),武汉430205 [5]广州市丹蓝生物科技有限公司,广州510200 [6]人福医药集团股份公司,武汉430075 [7]北京孚睿湾知识产权代理事务所,北京100032 [8]金泽工业大学大学院,东京都105-0002 [9]武汉光谷生物产业基地建设投资有限公司,武汉430075

出　　处：《中国新药杂志》2024年第17期1745-1751,共7页Chinese Journal of New Drugs

基　　金：国家社会科学基金资助项目:专利到期药物仿制上市法律保障机制研究(18BFX168)。

摘　　要：本文以生物医药领域为视角,分别介绍了美国专利持续申请制度的法律来源,其包含3种类型(继续申请、分案申请、部分继续申请)及具体内容、该制度与中国专利分案申请制度的区别。分别以苯甲酸阿格列汀和达妥昔单抗为例,详细介绍了美国专利持续申请制度在药物研发及专利布局中的应用,通过具体案例指出该制度对我国制药企业的参考与启示作用,如利用继续申请等进行专利布局或通过部分继续申请和继续申请的组合策略进行专利布局,以构建不同权利要求范围的多件专利组合,最大范围地保护产品的技术特征。From the perspective of the field of biomedicine,this paper introduces the legal sources of the subsequent application system of the United States patent,which includes three types(continuation application,divisional application and continuation⁃in⁃part application),and their specific contents,the difference between this system and the divisional application system of Chinese patent.Taking alogliptin benzoate and dinutuximab as examples,this article introduces the application of subsequent application system of the United States patent on drug research and development,and patent layout in details.Through these specific cases,this paper points out the reference and the enlightenment of this system for Chinese pharmaceutical enterprises,for examples,using continuation application for patent layout,or through the combination strategy of continuation⁃in⁃part application and continuation application for patent layout,in order to build a combination of multiple patents with different scope of claims and to protect the technical characteristics of the product for the largest range.

关 键 词：美国专利 持续申请 继续申请 分案申请 部分继续申请 药物研发 专利布局 

分 类 号：R95[医药卫生—药学]